Benign Anal Disease: Who Are the Right Candidates for Sacral Nerve Stimulation?


P (Patients)

I (Intervention)

C (Comparator)

O (Outcomes)

Patients with FI

Sacral nerve stimulation

All other interventions

Success of therapy, decrease in FI episodes, change in CCIS, morbidity





Results


In the SNS studies reviewed, 55–100 % percent of patients had a successful peripheral nerve evaluation (PNE) test as defined by >50 % improvement in FI severity during the testing phase. A successful PNE test is highly predictive of a successful permanent implant. Preoperative anal physiology testing and ultrasonography do not appear to be predictive of SNS success for the management of fecal incontinence [19]. Factors associated with failure of PNE testing phase include increased age [20, 21], defects in the external anal sphincter [20, 22], and repeated PNE attempts [20, 22]. However, if a PNE test was successful, the aforementioned factors were not associated with reduced success of a permanent implant [22].

Of the SNS studies reviewed, the majority were prospective case studies with only two randomized trials [23, 24]. Most studies were of moderate to low quality evidence by the GRADE approach [18] and were limited by the lack of a direct comparator. In a randomized double blind crossover trial, there was a significant improvement in frequency of episodes, symptom severity, and quality of life during the device ON versus device OFF phase, indicating that improvement was due to the device and not due to placebo [23]. When SNS was compared to optimal medical management in a randomized controlled trial, those treated with SNS had a statistically significant improvement in weekly fecal incontinence episodes (from 9.5 to 3.1) and an improvement in quality of life [24]. Further, 47.2 % of patients achieved perfect continence with SNS. In contrast, the optimal medical management group had no improvement in fecal incontinence, nor quality of life scores. Meurette et al. compared SNS to artificial bowel sphincter (ABS) and noted that the SNS had higher postoperative CCIS scores (9.4 vs. 4.7), but less constipation and a similar improvement in quality of life [25]. Additionally, there was no significant morbidity in the SNS group while 53 % of patients in the ABS group required further surgical revision due to mechanical failure or ulceration/erosion of the anal canal. Aside from these studies, there are no other direct comparative studies of SNS versus alternative therapies.

The success rates for SNS based upon an improvement of at least 50 % in FI severity following permanent implantation are shown in Table 38.2, in a per protocol analysis (success of patients who received a full-system implantation). Overall, 54–100 % of patients undergoing permanent implantation experienced a statistically significant greater than 50 % improvement of FI in all follow up stages. Perfect continence was achieved in 4–73 % of patients. Table 38.2 demonstrates an improvement in CCIS score across all follow up lengths. SNS therapy for FI was shown to be effective in studies with follow-up as long as 9 years [51, 78], though patients need ongoing follow up; many patients will need a battery change or lead revision over time [82].


Table 38.2
Outcomes following permanent implantation with sacral nerve stimulator



















































































































































































































































































































































































































































































































































































































































































































































































































Study

Study type

Grade

Temp PNE/Perm implant

F/U (months)

% Patient improvement

CCIS

FI episodes

>50 %

100 % continent

Baseline

F/U

Baseline

F/U

Kenefick [26]

PS

Low

15/15

24


73.3
   
11

0

Ripetti [27]

PS

Low

21/4

15

100
 
12.2
 
12

2

Ratto [28]

PS

Low

10/10

           

Matzel [29]

PS

Low

37/34

23.9

88

39.4
   
16.4

2

Jarrett [30]

PS

Low

59/46

12

100

41.3

14

6

7.5

1

Rasmussen [31]

PS

Low

43/37

6

86
 
16

6
   

Uludag [32]

PS

Low

75/50

12
       
7.5

0.67

Altomare [33]

PS

Low

14/14

24
       
7

1

Jarrett [34]

PS

Low

13/12

12


41.7
   
9.33

2.39

Jarrett [35]

PS

Low

16/16

24

100

25
   
12

1.5

Leroi [23]

RCT

High

34/28

6


26.3

16

8.5

7

1

Hetzer [36]

PS

Low

20/13

1

100
 
14

4
   

Uludag [37]

PS

Low

14/14

1

100
     
8.7

0.67

Michelsen [38]

PS

Low

29/29

6

100
 
16

4
   

Faucheron [39]

PS

Low

40/29

6

 
17

6
   

Kenefick [40]

PS

Low

19/19

24

100

73.7
   
12

0

Holzer [41]

PS

Low

36/29

35

     
7

2

Gourcerol [21]

PS

Low

61/33

12

69

21

14.4
 
5

1

Hetzer [42]

PS

Low

44/37

13

91.9
 
14

5

8

2

Melenhorst [43]

PS

Mod

134/100

25.5

81
     
31.3

4.8

Navarro [44]

PS

Low

26/24

12

100
 
15

4.87
   

Tjandra [24]

RCT

High

60/53

12

71

47.2

16

1

10

3

Jarrett [45]

PS

Low

8/8

26.5

75
     
5.5

1.5

O’Riordan [46]

PS

Low

14/10


100
 
16

5
   

Munoz-Duyos [47]

PS

Low

47/29

34.7

86.2

48.3
   
7.1

<1

Dudding [48]

PS

Low

70/51

24

85.4

39.6
   
6

0.5

Roman [49]

PS

Low

18/18

3

77.8
 
14.9

4.9
   

Stelzner [50]

PS

Low

20/13

10
       
9.9

4.5

Meurette [25]

PS

Mod

A: 15

43
         
A: 5.6
     
B:27/15

15
         
B: SNS

Matzel [51]

PS

Low

12/12

118

77.8

44.4

17

10
   

Altomare [52]

PS

Low

94/60

74

74

18

15

5

4

1

Govaert [53]

PS

Mod

208/145

31

80
         

Vallet [54]

PS

Low

45/32

33

71.9

4.3

16.1

10
   

Oom [55]

PS

Low

46/37

32

81.1

5.4
   
9

0

Koch [56]

PS

Low

35/19

24

89.5

21
   
11

2

Otto [57]

PS

Low

14/14

6
   
16.3

9.6
   

Wexner [58]

PS

Mod

133/120

28
   
39a

30a

9.4

2.9

Michelsen [59]

PS

Mod

177/142

24

54
 
16

10
   

Wexner [60]

PS

Mod

133/120

28

83

41
   
9

2

Maeda [61]

PS

Mod

191/191

   
16
 
14.5
 

Faucheron [62]

PS

Mod

123/87

48.5
   
13

8.2
   

Lombardi [63]

RS

Low

16/11

38

100

27.3

19.91

6.82

5

1

Uludag [64]

PS

Low

12/12

6
   
13.09

4.91

4.55

1.32

Uludag [65]

PS

Low

50/50

85

84
     
8

0

Soria-Aledo [66]

PS

Low

23/23

       
3.1

0.5

Gallas [67]

PS

Mod

200/200

12

67.3
 
12

7
   

Hollingshead [68]

PS

Low

113/86

21.5

83
 
15

9

9

1

Lim [69]

PS

Low

80/53

54
   
11.5

8
   

Mellgren [70]

PS

Mod

133/120

3

86

40

39.9a

29a

9.4

1.7

Maeda [71]

PS

Mod

245/176

13
           

Boyle [72]

PS

Low

50/37

17

81.8

39.4

15

8

14

2

Wong [73]

RS

Low

91/61

31
   
14.3

7.6
   

Devroede [74]

PS

Mod

133/120

39

85.9

33.3

39.9a

28a

9.4

1.9

Faucheron [75]

PS

Low

57/49

62.8
   
14.1

6.9
   

George [76]

PS

Low

30/23

44

100

56

19a

10a

10

0

Dueland-Jakobsen [77]

PS

Mod

129/129

46

75

36
   
19

2.5

George [78]

PS

Low

25/23

114
   
20

8

22

0

Santoro [79]

PS

Low

28/28

6
 
68

16

3

14.7

0.4

Benson-Cooper [80]

PS

Low

29/27

10.7
       
7.25

1

Damon [81]

PS

Mod

119/102

48

75.5
         

Hull [82]

PS

Mod

133/120

60

88.9

36.1

38a

28a
   

McNevin [83]

PS

Low

33/29

       
19

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Jul 13, 2018 | Posted by in ABDOMINAL MEDICINE | Comments Off on Benign Anal Disease: Who Are the Right Candidates for Sacral Nerve Stimulation?
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